Negotiating Strategy for Novel Infectious Diseases Clinical Trial

 

HIV/AIDS, tuberculosis, malaria and neglected tropical diseases cause significant morbidity and mortality in developing countries, and account for 11.4% of the global disease burden. Yet, only 1.3% of the 1,556 new drugs approved between 1975 and 2004 were specifically developed for these diseases (DNDi 2015). Over a dedicated three-month period, we helped a major health organisation which had been awarded grant funding to join the fight in finding a cure for one of these diseases.  

 

Drawing on a highly reputed team of influential subject matter experts in: commercial and clinical research, and negotiations, licencing and collaborating with legal counsel in the pharma industry; public-private partnerships; humanitarian decision-making; and strategic communications, particularly digital, we helped the organisation to align internally and:

 

• ensure a common understanding among their medical experts of the knowledge required to get the trial(s) off the ground;

• review their draft Protocol Synopses; 

• agree the attributes and elements of a Negotiation Strategy for the major pharmaceutical companies concerned; 

• equip the negotiation team to be sufficiently confident to execute the plan.